observational study evaluating long-term effectiveness of duodopa/duopa in patients with advanced parkinson's disease

Conditions: Advanced Parkinson's Disease

Summary: this study is a non-interventional post-marketing observational study (pmos) of participants with advanced parkinson's disease (pd) treated with duodopa/duopa in a routine clinical setting. effectiveness of treatment will be collected with physician and participant/caregiver health outcomes beginning with pmos enrollment (baseline visit), at the start of duodopa/duopa treatment via percutaneous endoscopic gastrostomy-with jejunal extension (peg-j), at regularly scheduled visits closest to months 3 and 6, and every 6 months thereafter up to 36 months. an additional cohort of participants will be enrolled who in addition will be evaluated with a wearable device.


Eligibility criteria:
inclusion criteria: * eligibility for duodopa/duopa therapy in accordance with the approved local duodopa/duopa label in the participating country. * duodopa/duopa naïve participants * decision to treat with duodopa/duopa made by the physician prior to any decision to approach the participant to participate in this study * prior to any study-related procedures being performed, the participant, or legal authorized representative (lar) has voluntarily signed an authorization for use/disclosure of data (audd)/informed consent form (icf) according to national regulations after the study has been explained and the subject has had the opportunity to have questions answered. * for arm b: participant and caregiver must be motivated to use the pkg, understand the instructions and be able to handle the device. * for arm b: participant must demonstrate at least 75% concordance with the investigator's or qualified designee's assessment of symptoms on the parkinson's disease diary following training at enrollment visit 1/v1 with concordance on at least 1 time interval of "off", concordance on at least 1 time interval of "on regardless of dyskinesia" and at least 1 time interval of "on with dyskinesia" irrespective of whether the dyskinesia are troublesome or not troublesome. exclusion criteria: * any condition included in the contraindications section of the approved local duodopa/duopa label in the participating country. * participants who have had previous surgery for pd including, but not limited to deep brain stimulation (dbs) or cell transplantation (this criterion removed for us sites for arm a). * participants currently in treatment with continuous apomorphine infusion. in case of a previous treatment with continuous subcutaneous apomorphine infusion, there must be at least 4 weeks between discontinuation of this treatment and inclusion into this study. * mini-mental state examination (mmse) score \<24 * participation in a concurrent interventional clinical trial. * lack of motivation or insufficient language skills to complete the study questionnaires

Keywords: advanced parkinson's disease duodopa/duopa carbidopa levodopa enteral suspension (cles) levodopa-carbidopa intestinal gel (lcig) off time motor and non-motor symptoms dyskinesia tremor quality of life observational long-term caregiver burden effectiveness fluctuations